March 2014

Why Antitrust Must Play a Role in Analyzing Drug Patent Settlements

Michael A. Carrier, Distinguished Professor, Rutgers School of Law, MJLST Guest Blogger

Think back several years to, say, 2006 or 2008. The world of drug patent settlements, by which brand-name drug companies pay generics to delay entering the market, was a far different place. A string of appellate courts–the Second, Federal, and Eleventh Circuits–had essentially immunized these agreements by applying a toothless framework based on the “scope of the patent.” The test applied by these courts assumed that the patent was valid and infringed and that a payment for delayed entry could not violate the antitrust laws.

In the landmark case of FTC v. Actavis, 133 S. Ct. 2223 (2013), the Supreme Court rejected such a narrow view. Writing for a majority of five, Justice Stephen Breyer concluded that these settlements “tend to have significant adverse effects on competition” and could violate the antitrust laws. The Court also found that such agreements could demonstrate market power and that the parties had ways to settle other than with payment.

In contrast, writing for three Justices in dissent, Chief Justice John Roberts downplayed antitrust law in contending that “the scope of the patent–i.e., what rights are conferred by the patent–should be determined by reference to patent law.” The claimed reason is that “a patent holder acting within the scope of its patent does not engage in any unlawful anticompetitive behavior” but “simply exercis[es] the monopoly rights granted to it by the Government.”

Roberts combined his exclusive preference for patent law with the position that activity within the nominal scope of the patent is immune from the antitrust laws. A patentee “acting within the scope of its patent has an obvious defense to any antitrust suit: that its patent allows it to engage in conduct that would otherwise violate the antitrust laws.” And even though he viewed “the question posed” as “fundamentally a question of patent law,” he lamented that “the majority declares that such questions should henceforth be scrutinized by antitrust law’s unruly rule of reason.”

My short article in the Minnesota Journal of Law, Science & Technology highlights three significant flaws with Roberts’ opinion. First, Roberts ignored the patent-law policy of challenging and eliminating invalid patents. Second, he downplayed the role of antitrust law. And third, he neglected the importance of the Hatch-Waxman Act, Congress’s resolution of the patent-antitrust intersection in the pharmaceutical industry.

First is patent law. Empirical studies have consistently shown that at least 40% of patents issued by the U.S. Patent and Trademark Office (PTO) that are litigated to decision are invalid. For that reason, the Actavis Court recognized the “patent-related policy of eliminating unwarranted patent grants so the public will not ‘continually be required to pay tribute to would-be monopolists without need or justification.'” Roberts’ suggestion to decide the issue solely on the grounds of patent law does not include this important aspect of patent policy.

Second is antitrust law. As the majority in Actavis recognized, reverse-payment settlements “tend to have significant adverse effects on competition.” Of all the types of business activity subject to the antitrust laws, agreements by which competitors divide markets could be the most dangerous since market division restricts all competition between the parties on all grounds.

Reverse-payment settlements result in generics dropping patent challenges and, in exchange for millions of dollars, agreeing to delay entry into the market. Because the brand makes more by keeping the generic out of the market than the two parties would receive by competing in the market, the parties have an incentive to cede the market to the brand firm and split the monopoly profits.

Third is the regulatory regime. As the Supreme Court has made clear, it is appropriate for courts applying antitrust law to “be attuned to the particular structure and circumstances of the industry at issue.” Congress resolved the tension between the patent and antitrust laws in the pharmaceutical industry by enacting the Hatch-Waxman Act.

The Act had a central purpose of encouraging challenges to invalid or not infringed patents during the term of the patent to encourage early market entry. Reverse-payment settlements directly contravene this goal by allowing brands to pay generics for delayed market entry. In short, not only does such conduct flout the patent policy of testing invalid patents and present significant antitrust harm, but it also disregards the Hatch-Waxman Act and important public-policy goal of increasing the number of affordable generic medicines.

As courts begin to interpret drug patent settlements in the wake of Actavis, they should not follow the approach to patent and antitrust law articulated by Chief Justice Roberts. For in addition to being rejected by the Supreme Court, it (1) shortchanges patent law, which includes a policy goal of testing invalid patents to ensure they do not block competition; (2) downplays antitrust law’s role in monitoring behavior that resembles market division between potential rivals; and (3) ignores the Hatch-Waxman Act’s encouragement of challenges to patents that are invalid and not infringed.

Cyberbullying Laws in Minnesota: An Update and Counterpoint

Erin Fleury, MJLST Staff

Bullying in schools is an age-old problem; the effects of which have been exacerbated by society’s increasing use of technology, especially social media. Minnesota has minimal legislation when it comes to bullying and although it does include cyberbullying, many argue that the state should do more to enable schools to crack down on bullying in general.

A University of Minnesota Law School student, Bryan Morben, recently wrote an excellent Note regarding cyberbullying in which he highlighted a bill that was working its way through Minnesota’s legislature. At the time his article was published, the bill had been passed by the House but was “effectively kill[ed]” by the Senate. Supporters were hopeful that it would be revived during the current legislative session, however, and on March 12 the Senate’s education committee recommended the passage of an amended version of the bill that was passed by the House last year.

Mr. Morben’s article suggests that the House bill would not be defective for being vague or overbroad but it seems as though the bill could actually be criticized because it may encompass behavior outside the scope of what the legislature is aiming to prevent. For example, the House bill may include conduct that would not be considered bullying by any common-sense definition but is merely distracting to the learning process. The bill defines bullying as “the use of … words, images, or actions … that a reasonable person knows or should know … will have the effect of materially interfering with the ability of an individual … to participate in a safe and supportive learning environment.” After the definition, an example is listed which states that bullying would include conduct that “interferes with a student’s educational performance or ability to participate in educational opportunities.” A ‘class clown’ who routinely interrupts the teacher and distracts other students would reasonably know that such behavior is interfering with the ability to participate in a supportive learning environment, yet that type of behavior should not necessarily be considered bullying since it does not have the same type of negative consequences on students. Yet the language may create authority for teachers to crack down on other types of disruptive behavior because of the potential broadness.

Furthermore, the bill imputes a reasonable person standard on the requirement that the bully know that they will materially interfere with the other individual, but there is no reasonable or objective standard in regards to what actually is a material interference. For example, if one student would unreasonably react to another student disagreeing with them in class in such a way that it “has a detrimental effect on [their] physical, social, or emotional … health” then that would still be considered bullying even though the unreasonableness was on the part of the bullied rather than the bully. While these arguments may be stretching the meaning of the bill (and there are certainly strong arguments for interpreting the bill more narrowly), the House’s proposed definition certainly seems to create ambiguity that could lead to serious concerns about the scope or even constitutionality of the law.

The Senate’s amended bill, on the other hand, remedies these defects by requiring that all bullying conduct be “objectively offensive.” It also requires more from the offensive activity than any word, images, or actions by only applying to “intimidating, threatening, abusive, or harming conduct.” What constitutes such conduct is further defined with the examples of “causing physical harm [or reasonable fear thereof] to a student or a student’s property … violates a student’s reasonable expectation of privacy, defames a student, … constitutes intentional infliction of emotional distress … [or] is directed at a student based on [a number of personal characteristics].” Unlike the House’s bill, every example requires some form of objective or reasonableness requirement. While the definition itself explains that these examples are not all-inclusive, they do seem to point much more directly at bullying actions rather than other types of disruptive behavior. In this regard, the Senate proposal seems like a stronger piece of legislation because not only is it less likely to be contested on legal grounds, but its scope is also better targeted at the specific problem Minnesota is trying to address.

So far the amended bill has only been put forward by committees and not voted on by the entire Senate but it will be interesting to keep any eye on any future revisions and to see what version, if any, might be enacted into law.

Revisiting the Legality of Physician-Assisted Suicide

Alison Key, MJLST Staff

Already this year, two states have expanded options for physician-assisted suicide (PAS) by striking all or part of statutes designed to criminalize the end of life treatment.

In January, a state trial court in New Mexico reviewed NMSA § 30-2-4, which prohibits physician-assisted suicide. The New Mexico trial court ruled that patients have a right under the State’s due process clause to choose to pursue a physician’s aid in dying, therefore the state law violated the state’s constitution. Commentators expect this ruling to be reviewed by the New Mexico Supreme Court, or possibly expanded to other districts through similar trial court decisions.

In Minnesota, the victory was smaller, but application more widespread. Last week, the Minnesota Supreme Court struck portions of the Minnesota law prohibiting assisted suicide as unconstitutional. The Minnesota Supreme Court held that the Minn. Stat. § 609.215, which prohibits “intentionally advis[ing], encourag[ing], or assit[ing] another in taking the other’s own life” was in conflict with First Amendment rights to free speech. Of the three actions prohibited in the statute, “advising” and “encouraging” suicide, the Minnesota Supreme Court ruled, are protected under the First Amendment.

While the Minnesota case was determined on constitutional grounds largely irrelevant to the ethics of PAS, both the Minnesota and New Mexico decisions have contributed to the larger, national trend of eliminating the legal barriers to PAS as a medical treatment. These two recent cases are significant in the larger debate on physician- and health care provider-assisted suicide, which has been gaining increased attention in recent years.

Minnesota and New Mexico, before this year, belonged to a majority of states that banned assisted suicide. (A few states, like Minnesota, also banned “encouraging” or “advising” suicide; these laws are rare because of First Amendment complications.) While there is no federal legislation on the subject (the Supreme Court in Washington v. Glucksberg held only that there is no right to PAS under the federal due process clause), four states have legalized PAS: Montana, Oregon, Vermont, and Washington. The ongoing litigation in New Mexico may soon bring that number to five. Three of these four states (Oregon, Vermont and Washington) legalized PAS through legislation or referendum, while Montana and parts of New Mexico have legalized PAS through state judicial precedent (in 2008 and 2014, respectively; the New Mexico decision from last January is currently only applicable in one district). Because all legalization efforts have occurred in the last three decades, the trend to eliminate legal barriers to PAS appears to be a recent one. Oregon has the oldest PAS law on the books, from 1994, while the remaining states have all legalized PAS since 2008.

In addition to the recent trend to legalize PAS, another interesting trend is the division in support for PAS between the public and experts. Among those presumed to be experts (based on subscription to the New England Journal of Medicine), about 67 percent of those polled in the United States indicated opposition to PAS. One of the more vocal opponents of PAS is a physicians’ professional organization: the American Medical Association. The AMA takes the position that PAS is “fundamentally inconsistent with the physician’s role” and is an improper extension of the right to refuse treatment. The AMA’s published opinion has remained unchanged since 1996, suggesting it is not reflective of the current trends toward more liberal PAS laws.

Conversely, the public tends to support PAS, if termed correctly. A Gallup poll last May indicated that 70 percent of the public agreed that “when patients and their families wanted it, doctors should be allowed to ‘end the patient’s life by some painless means.'” The favorable percentage dropped to 51 percent when the question was changed to include the word “suicide,” suggesting a social connotation of the word suicide, rather than disapproval of the act itself. The public’s pro-PAS view seems to be driving the current trend to remove legal barriers to PAS.

It is clear that the hard stance against PAS has eroded in recent decades. The New Mexico state trial court decision in January announced, “[c]ertainly the medical and legal ethical considerations regarding end of life care have changed over the past fifty years. ” Last year alone, six states introduced bills to directly legalize PAS, including Connecticut, Vermont (passed), New Jersey, Kansas, Hawaii, and Massachusetts. In four other states, bills related to the issue of PAS, short of full legalization were introduced.

After the Minnesota Supreme Court ruling last week, another case on assisted suicide pending before the Minnesota Supreme Court has the public’s attention. With yet another PAS case coming before the Minnesota Supreme Court, New Mexico courts contemplating the expansion of the trial court ruling across the state, and bills becoming a frequent occurrence in other states, PAS legalization is becoming a trend to watch–in Minnesota, New Mexico, and nationally. With baby boomers nearing the age where end of life decisions become more pressing, discussions about legalizing PAS to expand end of life options will become more prevalent and more urgent.

Will Sodsaver Save the Prairie Pothole Region?

Joe McCartin, MJLST Staff

In recent years, high crop and farmland prices, in combination with technological advances in agriculture, have pushed crop producers to convert virgin prairie at an alarming rate. Minnesota, for example, was once covered in prairie. Yet, today only 1% remains of the 18 million acres that once covered the state, and that too has come under threat. Exacerbating the problem is the fact that federal subsidies and crop insurance treated crops equally even if they were being grown in an ecologically destructive manner. A crop producer received taxpayer support even for corn and soybeans grown on virgin prairie that had just been plowed-under. These were often areas once considered marginal for crop production, but they held enormously high value for wildlife and helped protect water quality from other agricultural erosion and pesticide and fertilizer pollution.

The recently passed Farm Bill, the Federal Agricultural Reform and Risk Management Act of 2014, included a new program, Sodsaver, proposed by Ducks Unlimited and advanced by a diverse array of organizations, from the Theodore Roosevelt Conservation Partnership and Trout Unlimited to the Union of Concerned Scientists and the World Wildlife Fund. The program aims to shift the incentives that make the plowing of virgin prairie so appealing. It works by preventing farmers from enrolling virgin prairie, land that has not been planted with crops previously, in the federal crop insurance program. Since subsidies will slowly be phased-out for most crops, preventing access to crop insurance will prevent taxpayers from footing the bill for the ecologically damaging process of planting on virgin prairie. By forcing farmers to rely entirely on free-market forces for crops grown on this land, Sodsaver hopes to make the often lucrative decision to plow the prairie riskier for crop producers. Unfortunately, the program was only implemented in a limited number of states that make up the Prairie Pothole Region – Minnesota, Montana, the Dakotas, Iowa, and Nebraska.

Because the program does not mandate that crop producers preserve their native, virgin prairie, but merely withholds taxpayer support if the decision is made, it is forecast to save taxpayers nearly $120 million over 10 years. These savings could grow substantially if the program had not been limited to a handful of states. However, the important question remains unanswered, will this change the behavior of crop producers. While removing crop insurance coverage seems to be a logical first step in stemming the tide of prairie loss, it is only a first step. Whether it will be enough will depend heavily on crop prices and actions by grassland states to protect and restore these priceless ecological resources. A diverse array of migratory waterfowl and songbirds very survival depends on the success of Sodsaver in these trial states, and the program’s expansion into all grassland states.

The author served on the Policy Council of the Theodore Roosevelt Conservation Partnership, one of the supporters of the Sodsaver program.

E-Cigarette Trend Will Likely Subside After Federal and State Regulation Weighs In

George David Kidd, MJLST Managing Editor

Who could have predicted that development of better portable-battery technology would unleash such a radical transformation of tobacco consumption? By vaporizing nicotine-infused water vapor via the e-cigarette, the new trend, called “vaping,” has certainly turned a few heads. Not only has the use of electronic cigarettes doubled among middle and high school students from 2011-2012, but Bloomberg Industries predicts that the sale of electronic cigarettes might surpass the sale of other tobacco products by 2023. As of 2014, e-cigarette sales are still growing rapidly. Bold predictions in e-cigarette sales growth, however, fail to take into account the role that tobacco regulation will play in discouraging the trend. Federal and state regulations have yet to definitively weigh in on the issue.

Despite its announced plans to regulate e-cigarettes as tobacco products in 2011, the FDA has not yet taken action. Future FDA regulation will almost certainly be modeled upon current tobacco regulation to the extent that e-cigarettes are comparable to combustible tobacco products. For example, nicotine is still addictive. It can still be dangerous for those with heart problems and might cause other cardiovascular ailments over time. Those who stop the consumption of nicotine may face withdrawal symptoms that could include irritability, depression, restlessness, and anxiety. However, e-cigarette vapor avoids consumption of carcinogenic chemicals in smoke that are released by the combustion process.

To the extent current federal tobacco regulations are concerned with the direct consumer consequences of smoking, such as the disclosure of ingredients, labeling requirements, and ingredient quality, FDA regulation of e-cigarettes will closely mirror that of traditional tobacco products. Consequently, quality-control procedures and required labeling will only serve to increase the cost of e-cigarettes to consumers, and discourage sales.

State laws, such as those discussed in Smokers: Nuisances in Belmont City, California–In Their Homes, But Not on Public Sidewalks, by Georges Tippens, are primarily concerned with the effects of secondhand smoke. As of 2014, most states have banned smoking in enclosed public places due to concerns over the dangers of secondhand smoke. However, there is no definitive study as to whether e-cigarette vapor has any secondhand effect. Some states are, nevertheless, proactively seeking to extend current regulations, which ban smoking in enclosed public areas, to e-cigarettes. Other states, however, seem to be waiting until more information becomes known about whether e-cigarette smoke is harmful.

Even if e-cigarette vapor is found to be harmful, the question of whether e-cigarette vapor is “as dangerous” as the smoke produced by traditional combustible tobacco products will take decades of research to answer. In this day and age, if scientific evidence provides that secondhand smoke does have a secondhand effect on others, it is improbable that the question of how similar e-cigarettes are to traditional combustible products will have any impact on the extent of state regulation. In this case, e-cigarette regulation will feasibly mirror current state regulations that ban the use of combustible tobacco products in enclosed public places, and will provide a disincentive to e-cigarette sales.

BP’s Deep Water Horizon Oil Spill Litigation Drags on in the Eastern District of Louisiana

Daniel Schueppert, MJLST Staff

With the recent celebration of Mardi Gras not long past, Louisiana and other southern coastal states are once again making national news. Meanwhile, in the background of these festivities, lawyers and the courts are toiling away at ongoing litigation arising from the Deep Water Horizon oil spill: a spill that began almost four years ago, lasted at least eighty-seven days, and caused the deaths of eleven people.

In 2012 Daniel Farber published an article titled The BP Blowout and the Social and Environmental Erosion of the Louisiana Coast in vol. 13 of the Minnesota Journal of Law, Science & Technology. In his article, Professor Farber analyzed the pre-spill, post-spill, and anticipated condition of the oil-affected coastal states. Many of the issues identified in his paper continue to be troubling in light of the disruption caused by the oil spill. In addition to the environmental and regulatory issues that face these states, the Eastern District of Louisiana is embroiled in a prolonged legal battle related to destruction of digital evidence that might have made a difference before or during the well blowout.

Kurt Mix was a drilling engineer for BP assigned to the Deep Water Horizon at the time of the blowout off the coast of Louisiana in April, 2010. In the course of his work, Mix had access to, and a degree of control over the production of, internal BP data about the rate and amount of oil flowing out of the damaged Macondo Prospect well upon which the Deep Water Horizon was sited. BP publicly issued statements that the well had a flow rate at the time of about 5,000 barrels daily, but during the same period, BP and Mix’s team allegedly knew that the rate was closer to 64,000 to 146,000 barrels per day, according the government’s related complaint against BP directly.

In May, 2012 “Mix was charged by the United States in a two count indictment with obstruction of justice in violation of 18 U.S.C. § 1512(c)(1). . . . based on his allegedly deleting certain iPhone texts to BP’s then-Drilling Engineering Manager . . . .” for the region and a third party contractor who was assisting with the spill and blowout response. U.S. v. Mix, 12-171, 2012 WL 2420016 (E.D. La. 2012). Mix was found guilty on this obstruction charge despite having previously released that information to U.S. government representatives, and according to a Forbes article, Mix’s disclosures were a primary source comprising the basis of the government’s claims against BP. He is the only natural person to have had claims related to the oil spill stick. The content of the texts themselves have so far not been recovered despite his conviction, which raises questions about the procedural management and prosecutorial discretion used in this collection of cases related to the Deep Water Horizon blowout. Following Mix’s conviction, there has been a procedural dance of more than twenty actions between the United States and Mix, touching on issues of attorney privilege, judicial conflicts of interest, criminal and civil procedure, and proportional liability for allegations based on extinct digital evidence.

Breathalyzers v. Blood-Alcohol Tests

Jenny Nomura, MJLST Managing Editor

In the MJLST volume 11 spring edition, David Liebow discussed the difficulties of obtaining the source code of breathalyzers in DWI cases. In his note “DWI Source Code Motions after Underdahl” Liebow argues for easier breathalyzer source code access for DWI defendants. Obtaining the breathalyzer source code could help DWI defendants show the unreliability of the machine. In the years following the note, not much appears to have changed. And in some states it might not change for a long time, if ever.

The Minnesota Supreme Court received a case in which the source code of the Intoxilyzer 5000EN was in question (In re Source Code Evidentiary Hearings in Implied Consent Matters, 816 N.W.2d 525 (Minn. 2012)). The District Court had accepted the testimony of the state’s expert witness that the device was accurate, and the Minnesota Supreme Court affirmed that holding. In a dissent, Justice Page stated that “a defendant may not raise the source code as a potential cause of an inaccurate or deficient sample.” Other states have reached a very different conclusion: that maybe breathalyzers shouldn’t be relied on. In Pennsylvania, a county judge held breathalyzers were not accurate above a reading of 0.15.

So what does the future hold for breathalyzers? There is a tangle of recent case law that might play a role in determining whether police use breathalyzers or blood-alcohol tests. In Pennsylvania, police have switched from relying on breathalyzers to blood-alcohol tests in response to the county judge ruling. However, in a recent United States Supreme Court case, Missouri v. McNeely, 133 S. Ct. 1552 (2013), the Court held police must obtain a search warrant or have exigent circumstances to have a blood-alcohol test done for a person arrested for a DWI. That case seems to push police back to relying on breathalyzers. But the Minnesota Supreme Court held in Minnesota v. Brooks, 838 N.W.2d 563 (Minn. 2013) that Brooks gave consent voluntarily and freely at the time of the arrest to submit to the blood-alcohol test, and therefore the police didn’t need a search warrant or exigent circumstances.

If police officers are able to obtain a blood-alcohol test, then the prosecution might not need to rely on the breathalyzer results in order to obtain a conviction. If the breathalyzer results “don’t matter” (“don’t matter” in the sense that the results aren’t used as evidence in court) then maybe the source code of the breathalyzer machines also “doesn’t matter.” Maybe the new focus will be on the blood-alcohol tests.

Lethal Injection, Moral Compunction

Becky Huting, MJLST Staff

Ohio inmate and convicted murderer Dennis McGuire was recently executed by lethal injection with a new combination of drugs. Ohio had run out of the standard drug pentobarbital because European manufacturers like Danish-based Lundbeck had imposed stringent restrictions on sales, prohibiting distribution to prisons that perform executions. In response to the shortage, the Ohio Department of Rehabilitation and Correction amended its policy to allow for the use of midazolam and hydromorphone, a combination that had never been used before in an execution.

MacGuire’s lawyers argued that he would “suffocate to death in agony and terror.” The State’s expert Dr. Mark Dershwitz indicated that he had no way of knowing the duration of time before the drugs would take effect. “There is no science to guide me on exactly how long this is going to take.” MacGuire’s execution took 24 minutes, with the man gasping for air between 10 and 13 minutes. Reporter Alan Johnson stated, “He gasped deeply. It was kind of a rattling, guttural sound. There was kind of a snorting through his nose. A couple of times, he definitely appeared to be choking,”

MacGuire was convicted of the 1994 rape and murder of 22-year-old Joy Stewart, who was seven months pregnant. Her body was discovered by hikers in a creek; her throat was cut and she had been sodomized. There are many people in our country who would say, “Serves him right, MacGuire got what was coming to him. Let him suffer an awful, painful, frightened death just as his victim did. Why should I care about what happens to an evil, unrepentant killer? The world is a better place now that he’s gone, and I’m glad it hurt.” Can you hear the rumble? Are these not the same individuals who care about the tenants of our good country? Do they not tout the glory of our constitution?

The eighth amendment is short, but it is probably most recalled for its last six words: “Excessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishments inflicted.” What does cruel and unusual punishment mean? Some say this is a subjective concept. Others, like Justice Brennan, have floated some principles one might consider (Furman v. Georgia, 408 U.S. 238 (1972)): it could be punishment that is degrading to human dignity or that which inflicts it in wholly arbitrary fashion. Is there a way, though, to administer the death penalty in a fashion that respects human dignity? Former British Cabinet Minister Michael Portillo established a set of principles he believes is effective: death should be quick and painless to prevent suffering, medical education should be provided to the executioner to prevent suffering caused by error, the death shouldn’t be gory (also to protect those carrying out the execution and arguably the witnesses), and you shouldn’t force the inmate to cooperate in his own execution.

Whether to be concerned with agony and suffering in a death row inmate is a subjective decision based in an individual and community sense of justice. Yet it would be hard to deny that there is a change in how this process is being administered. This resolute rumbling I refer to, it must too engage in a set of values checking. If your code is the Constitution, does this still fit under your interpretation of the 8th amendment? If your code is not the 8th amendment, do you justify your reception of this new method in lex talionis (an eye for an eye)? What is stopping you from carrying out justice yourself, and if you want to, do you actually want to participate in a civilized society? Why shouldn’t creating that be the goal; aren’t we slipping back toward a time where men were hanged in the public square? Are you okay with going back?

Virginia too is running out of pentobarbital, and is now adding the new drug Midazolam to its execution process, despite objections of the drug’s manufacturer, Hospira, which has publically objected to the use of their product for capital punishment. Undoubtedly, more capital punishment states will continue to follow Ohio’s lead, leading to more inmates reaching their lengthy, choking ends this way. One inmate, Michael Lee Wilson, had some expressive last words: “I love everybody…I love the world…love my daughters for me…I feel my whole body burning.” Are we going to stand by our convictions or are we going to recognize that something is amiss here? Are we civil or savage?

Genetic Testing: Thorny Ethical Puzzles in Returning Results From Researchers

Savir Punia, MJLST Lead Notes and Comments Editor

The Minnesota Journal of Law, Science and Technology Symposium article, The Role of Law in the Debate over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science, by Professor Susan Wolf, discusses the current issues researchers are facing with genetic testing. At present, there is a dramatic rise in genetic-based research and tissue banks seeking to discover the genetic mutations and disorders responsible for some of the worst ailments plaguing humans today. As researchers are able to gather data using increasingly sophisticated tools, researchers are finding things they are not looking for, including information that could make a big difference for a donor. According to the 2012 New York Times Article, Genes Now Tell Doctors Secrets They Can’t Utter, we are at an awkward interval where our ability to capture information is exceeding our ability to know what to do with it.

Currently, the federal government’s National Institute for Health (NIH) is funding projects, including Professor Wolf’s research project on return of results, in order to develop guidelines in this thorny subject area. Until then, researchers are operating with a heightened nervousness about when and how to disclose research results to study participants or their families. According to Professor Wolf’s symposium article, researchers are already expressing anxiety “that they must navigate between legal threat on both sides – liability for failure to return findings on one side, and liability for wrongly returning on the other.”

Given the current state, researchers are tasked with dealing with challenging situations on their own. For example, researchers studying genes unrelated to breast cancer notice members of one family have a breast cancer gene, does this obligate researchers to disclose this finding or not. Currently, a lot of this depends on the types of consent forms used in the research projects. For example, the New York Times article discusses to similar situations with very different results. In the first research project investigators discover that a family does have a breast cancer gene, but does not disclose it because the consent form stated no results would be returned, essentially tying the hands of the researchers. In another study, researchers discovered a woman who had a strong family history of breast and ovarian cancer did not carry her family’s breast cancer gene, and they decided on ethical grounds to breach their consent forms stipulations in order to inform the woman and her family. These types of situations are becoming an ever increasing problem, and with no guidance or base line rule issued by any public health organization, researchers will continue to get caught up in return of research results.

Genetic research has brought about rapid advancement and change in how we approach human health, but it also has brought about some great challenges. As important as genetic research is, the individual submitting to it must not be forgotten. As genetic researchers sequence whole genomes and discover mutations in research participants’ sequences, there will be more of an imperative to communicate those results back in order to help that participant seek preventative care. Moreover, genetics are unique in that mutations in one individual may affect that individual’s entire family. Research participants’ families have a stake in their family members’ genetic sequences, because what is discovered there could also affect their own lives. Whether to return results to family members is a much more controversial issue and includes certain traditional healthcare privacy rules. As genetics continue to grow and play an important part in our healthcare, issues such as the ones above will need to be clarified and outlined. Research in this area is occurring at a fast pace, and Professor Wolf and her colleagues will be watched closely as they work toward establishing guidelines to power genetic research into the future.

The High Cost of Medical Errors

Mayura Iyer, MJLST Staff

When we feel unwell, or have an injury, or are battling a serious condition, we turn to doctors and hospitals to take care of us and return us to health. But what if these professionals are actually adding to the harm? A recent study in the Journal of Patient Safety stated that between 210,000 and 440,000 patients each year suffer some type of preventable harm that contributes to their death. These numbers are staggering and make medical errors the third leading cause of death in America. With statistics like that, you would expect the problem to be the topic of every major headline, however, these facts are not well documented or disseminated.

John Grout, John Hill, and Arlen Langvardt discussed the prevalence and causes of medical errors and how to mistake-proof the healthcare industry in their article in Volume 14, Issue 1 of the Minnesota Journal of Law, Science & Technology. Their article stated that medical errors stem from the multi-factorial, complex nature of medical procedures and from the subjective component of providing medical care. However, the article goes on to suggest several ways in which medical errors can be minimized through “mistake-proofing” measures that have had great success in other industries. The article gives examples of a variety of mistake-proofing methods, from using devices to monitor staff hygiene to using computers to aid the process of prescribing medication.

So why, when there are ways to tackle the issue, are the rates of medical errors not improving? Part of the problem is the institutionalized culture of healthcare. There has historically been a pass of sorts for the errors of doctors, granting them a pardon for reasonable human error. Furthermore, there is a culture of overlooking the mistakes of colleagues – partly because of a fear of retaliation and partly because there is an unspoken rule of maintaining and protecting professional reputations. However, when the cost of error is equal to the value of human life, it is necessary to break down harmful practices and implement policies that will adequately address the problem of fatal medical errors.

Academics, administrators, and doctors themselves have recognized this issue and even suggested easily to implement methods of error reduction. Dr. Marty Makary, a surgeon at Johns Hopkins Hospital, has suggested simple ideas like using cameras to record medical procedures and electronically-published reviews and ratings to make healthcare providers more accountable and thus minimize errors. With the problem only increasing, it will soon be impossible for healthcare providers to ignore. But recognizing the problem is only the first step; the more complicated task will be implementing policies that address the issue and ensuring adequate compliance. However, with the insight offered by practitioners and academics alike, the solution to this problem seems within reach.